Erhan 2008.
Study characteristics | ||
Methods |
Study design: randomized controlled trial Study grouping: 4 groups, monoprophylaxis |
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Participants |
Baseline characteristics Placebo (group 1)
Ondansetron (group 2)
Granisetron (group 3)
Dexamethasone (group 4)
Included criteria: scheduled for laparoscopic cholecystectomy with general anaesthesia, between 21 and 75 years of age (mean 51.5 years) Excluded criteria: ASA III or IV; over 75 years of age; body mass index > 30; pregnancy; smoking; signs of gastrointestinal, endocrine, renal, hepatic, or immunological disease; use of opioids or tranquillizers less than 1 week before the operation; treatment with steroids; history of alcohol or drug abuse; history of motion sickness; preoperative diagnosis of gallbladder empyema and previous endoscopic sphincterotomy for common bile duct stones; conversion to open cholecystectomy Pretreatment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of motion sickness, perioperative opioids): no; (history of PONV): unclear |
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Interventions |
Intervention characteristics Placebo (group 1)
Ondansetron (group 2)
Granisetron (group 3)
Dexamethasone (group 4)
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Outcomes |
Vomiting (0 to 24 hours)
Vomiting (0 to 6 hours)
Vomiting (6 to 12 hours)
Nausea (0 to 24 hours)
Complete response (no PONV) in 24 hours
Adverse events (general notes in the publication, 24 hours' observation)
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Identification |
Sponsorship source: NA Country: Turkey Setting: inpatient, single‐centre Author's name: Yamac Erhan Institution: Department of Surgery, Faculty of Medicine, Celal Bayar University, Manisa 45040, Turkey Email: yamacerhan@yahoo.com Address: Department of Anesthesiology, Faculty of Medicine, Ege University, 35100 Izmir, Turkey Duration of study: NA Language: English Study's primary outcome: NA Trial registry number: NA |
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Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "patients were randomly divided into four groups" Judgement comment: no further information on sequence generation provided |
Allocation concealment (selection bias) | Unclear risk | Judgement comment: no statement |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "study medications were prepared by a technician anesthetist in identical 5 ml syringes and administered in a double‐blind fashion" |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "the incidence of nausea and vomiting was recorded during three assessment periods, 0–6 h, 6–12 h, and 12–24 h, by nursing staff without knowledge of which antiemetic the patients had received. Both..." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "all 80 patients enrolled in the study had their surgical procedures completed" |
Selective reporting (reporting bias) | Unclear risk | Judgement comment: no reference to a study protocol or trial registry number reported |
Other bias | Unclear risk | Quote: "the mean values for age, weight, height, time of surgery, and time of anesthesia are given in Table 1. Groups were comparable with respect to demographic data, time of surgery, and time of anesthesia" Judgement comment: baseline characteristics (age, weight, ASA): no. Potential effect modifiers (gender, duration of anaesthesia, non‐smoker, history of motion sickness, perioperative opioids): no; (history of PONV): unclear |